Abstract

The author explores the theme of xenotransplants as a problematic branch of transplantology by pointing out the particularities of the normative framework. A particular observation made is how the discipline of transplants from the deceased is marked by a lack of legislative expertise on the one hand, and on the other by a lack of implementation. The author next analyses clinical experimentation involving xenotransplants where we observe the laborious emergence of new models of regulation. However, the uncertainty of the normative framework regarding xenotransplants had led to search the European Union Treaty for useful indications for resolving the issue of whether or not they are lawful. In particular, by stressing the principle of precaution as per Art. 174, Par. 2 of the Treaty, credit has come to be lent to the approach taken by those who, on the basis of purely ethical considerations, believe it proper to suspend experimentation with xenotransplants until science reaches a better understanding of the risks related to this therapy. Under the same profile the author delves into the matter of the juridical dimension of this principle, making clear the tension between the principle itself and the personal dimension of the right to health and the subsidiary reach of the principle of precaution. A further topic dealt with in the work is the guiding principles of clinical experimentation and the application of the same to xenotransplants, particularly as regards therapeutic utility, informed consent and the application of the protocol of experimentation. Finally, the author considers the matter of xenotransplants in terms of criminal liability, with particular reference to the approach to liability for unpremeditated acts.